Insights+: The US FDA New Drug Approvals in April 2021

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Insights+: The US FDA New Drug Approvals in April 2021

Insights+: The US FDA New Drug Approvals in April 2021

The US FDA has approved 3 NDAs and 2 BLAs in April 2021, leading to treatments for patients and advances in the health care industry.

The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 24 novel products in 2021.

Additionally, last year in 2020, the US FDA has approved 121 novel products. PharmaShots has compiled a list of a total of 5 new drugs approved by the US FDA in April 2021

Supernus Qelbree (SPN-812) Receives the US FDA's Approval for the Treatment of ADHD

Published: April 2, 2021 | Tags: Supernus, Qelbree, SPN-812, US, FDA, Approval, ADHD

  • The approval is based on data from an extensive development program that consists of four P-III clinical trials evaluating Qelbree in 1000+ pediatric patients aged 6 to 17 yrs. with ADHD
  • The program demonstrated the proven efficacy and a tolerable safety profile. In Dec'2020, the company reported the results from the P- III trial for Qelbree and plans to submit an sNDA to the FDA in H2'21
  • Qelbree is the first novel non-stimulant treatment for ADHD. The company plans to make it available in the US in Q2'21

Mayne Pharma Nextstellis Receives the US FDA's Approval for the Prevention of Pregnancy

Published: April 16, 2021 | Tags: Mayne Pharma, Nextstellis, US, FDA, Approval,Pregnancy

  • The FDA has approved Nextstellis (3 mg, DRSP, and 14.2 mg, E4 tablets) for the prevention of pregnancy and is expected to be commercially available in Jun'2021
  • The P-III study demonstrated the efficacy of Nextstellis across all subgroups through age, BMI and prior hormonal contraception use. The therapy is also associated with favorable bleeding control, including in cycle 1.
  • Nextstellis is the 1st oral contraceptive pill containing E4 and is safe, effective, and well-tolerated in clinical trials with a desirable bleeding profile and minimal impact on triglycerides, cholesterol, glucose, as well as weight and endocrine markers

ADC Therapeutics Zynlonta (loncastuximab tesirine-lpyl) Receives the US FDA's Approval for the Treatment of R/R Diffuse Large B-Cell Lymphoma

Published: April 23, 2021 | Tags: ADC Therapeutics, Zynlonta, loncastuximab tesirine-lpyl, US, FDA, Approval, Treatment, R/R Diffuse Large B-Cell Lymphoma

  • The approval is based on data from the P-II LOTIS-2 trial involves assessing Zynlonta in adults with r/r DLBCL following two or more prior lines of systemic therapy
  • Results: ORR (48.3%); CRR (24.1), PR (24.1%), and mDoR in 70 responders (10.3mos.) with a median time to response of 1.3 mos. The therapy will be commercially available in the US imminently
  • Zynlonta is the 1st CD19-targeted ADC approved as a monothx. for adult patients with r/r DLBCL. The company has launched the patient support program to provide financial assistance, education, and other resources for patients who are prescribed the therapy

Hikma KLOXXADOTM (naloxone hydrochloride) Receives the US FDA's Approval for the Treatment of Opioid Overdose

Published: April 30, 2021 | Tags: Hikma, KLOXXADOTM, naloxone hydrochloride, US, FDA, Approval, Opioid Overdose

  • The US FDA approved KLOXXADOTM (Nasal Spray, 8mg) for the emergency treatment of opioid overdose observed in respiratory and/or CNS depression in adult and pediatric patients.
  • In a survey, Narcan (Nasal Spray, 4mg) showed 34% attempted reversals used two or more doses. A separate study published in 2019 showed that the percent of overdose-related emergencies in the US requiring multiple doses of naloxone during 2013-2016 increased to 21% which represented a 43% increase over 4 years
  • KLOXXADOTM contains double the amount of naloxone per spray as Narcan in a ready-to-use nasal spray and it is expected to be available in H2'21

Related Post: Insights+: The US FDA New Drug Approvals in March 2021


Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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